The Regulation (annex I) Mentions That ‘During The Design Development Phase, Clinical Evaluation Is Required To Determine The Clinical Data Needed For Premarket Product Evaluation, To Determine Whether A Clinical Trial Is Needed And The Clinical Endpoints That Need To Be Observed’ Is That Not Very Similar To The EU Clinical Evaluation Plan? How Should It Be Documented?

They are different from EU CEP. CEP (clinical evaluation plan) is just a planning document which contains the scoping and methodology of clinical evaluation. However, during the design development phase, you have to do the actual clinical evaluation. This is the process you use to determine whether you have sufficient amount of clinical evidence. How should it be documented? This should be documented internally. I don’t think you need to submit this document to the agency.